Alcohol Use Disorder (AUD)NCT06303778
Combining a Smartphone App With Medications to Manage Heavy Drinking
A study testing Stand Down mobile app in people with Alcohol Use Disorder (AUD), run by VA Office of Research and Development at 15 sites in United States.
Trial summary
One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Stand Down mobile app
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Nov 2024to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible, Veterans must be:
- 1) diagnosed with an alcohol use disorder (AUD) and report 4 heavy drinking days (HDD)
- (defined as 5 standard drinks per day for men and 4 standard drinks per day for women) in prior 30-days
- 2) enrolled in VA primary care
- 3) planning to initiate medications for alcohol use disorder (MAUD), as determined by a medication order
- 4) willing to be randomized
- 5) Android or iPhone smartphone owners
Who cannot join
- 1) past 30-day participation in VA or non-VA substance use disorder (SUD) treatment
- 2) prior episode of medications for alcohol use disorder receipt in the last 30 days (initiation of a new episode of MAUD in the 7 days prior to screening allowed)
- 3) plans to be or are pregnant
- 4) severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol, as determined by the referring provider. Veterans aged >80 were excluded because ownership and use of mHealth apps decreases with advancing age. Participants who enter substance use disorder specialty care following randomization will be allowed to continue in the study.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Battle Creek VA Medical Center, Battle Creek, MI
Battle Creek, Michigan, 49037
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
Carl Vinson VA Medical Center, Dublin, GA
Dublin, Georgia, 31021
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
Veterans Health Care System of the Ozarks, Fayetteville, AR
Fayetteville, Arkansas, 72703-1944
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Anissa N Danner, MSW BA, (206) 277-4878, anissa.danner@va.gov
Hildi J. Hagedorn, PhD
- Recruiting
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229-4404
Anissa Danner, MSW, Anissa.Danner@va.gov
- Recruiting
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
Thomas S Bundt, FACHE, (253) 583-3500, thomas.bundt@va.gov
Susan Perez, BA, (202) 461-6910, susan.perez@va.gov
- Recruiting
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422-0001
Anissa Danner, MSW, Anissa.Danner@va.gov
About this study
One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally.
Read the detailed description
Background: Alcohol use disorder (AUD) affects 1 in 10 Veterans and is associated with significant morbidity and mortality. However, few individuals receive evidenced-based psychosocial interventions or medications for AUD (MAUD). Common barriers to treatment include long wait times, stigma, and distance from treatment facilities. Despite clinical guidelines and evidence indicating superior outcomes, even fewer individuals receive MAUD and psychosocial interventions conjointly. The VA prioritizes expanding access to AUD interventions in primary care, but it is difficult to deliver psychosocial interventions in primary care, and care often includes MAUD only. Smartphone mobile applications (apps) that deliver psychosocial interventions concurrent with MAUD may address the gap between recommended and current practices for AUD and appeal to Veterans who prefer to receive their AUD care in primary care. Alcohol intervention apps have been associated with improved drinking-related and mental health outcomes. Self-monitoring of alcohol use, a common feature in apps, may also increase MAUD adherence. Step Away, an app for self-management of alcohol use problems, is designed to guide development and use of personalized strategies to moderate or abstain from drinking. In single-arm cohort studies, the investigators assessed the acceptability and usability of Step Away and Stand Down (SD-App), the Veteran version of the app and focus of this proposal, among Veterans with alcohol use problems. The apps received favorable ratings regarding perceived effectiveness, efficiency, and overall satisfaction, and were associated with reductions in heavy drinking days and drinking-related consequences.
Significance: This study has the potential to substantially improve Veterans' receipt of guideline-concordant AUD care and support national VA initiatives to increase access to AUD care in general healthcare clinics.
Innovation \& Impact: To the investigators' knowledge, no prior study has evaluated the effectiveness of an alcohol-related intervention, delivered by smartphone, with MAUD in primary care. Smartphone apps can be scaled up at relatively low cost, potentially saving lives and improving the quality of care of tens of thousands of Veterans.
Specific Aims: The two aims are to: 1) determine whether MAUD plus SD-App offered to primary care patients diagnosed with AUD, compared to MAUD only, results in (a) greater reductions in heavy drinking days, from baseline to 6-months (primary), (b) greater improvements in alcohol consequences, alcohol use risk levels, and mental health outcomes, from baseline to 6-months (secondary), 2) conduct a process evaluation to identify factors that influence the adoption, implementation, and sustainability of SD-App in combination with MAUD in VA primary care from Veterans', clinical pharmacist specialists' and clinical leaders' perspectives. The investigators will also explore whether MAUD plus SD-App increases MAUD 6-month adherence relative to SD-App alone.
Methodology: Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, this Hybrid 1 effectiveness-implementation trial will enroll 330 Veterans across 15 VA sites. Veterans between ages 18-80, meeting AUD criteria, and planning to initiate MAUD will be randomized to MAUD+SD-App or MAUD only. Participants randomized to MAUD+SD-App will receive access to SD-App. MAUD will be prescribed by VA clinical prescribers per standard care. The primary and secondary outcomes will be assessed at baseline, 3-, 6- and 12-months using participant self-report and electronic medical record data. The investigators will complete qualitative interviews to assess Veterans', clinical pharmacists', and clinical leaders' perspectives on barriers and facilitators to adoption, implementation, and sustainability of SD-App in combination with MAUD in primary care.
Next Steps/Implementation: If MAUD+SD-App improves drinking outcomes, the investigators will work closely with the operations partners to review study findings and to develop a tailored implementation strategy to support widespread implementation across VA primary care.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Stand Down mobile app, Standard Care
- Keywords
- alcohol use disorder, substance use disorder, medications for AUD, smartphone app, primary care, mobile health
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stand Down mobile appOther
The Stand Down mobile app is a smartphone-based stand-alone intervention designed to help persons manage drinking and alcohol-related problems on their own. The app is based on principles of motivational enhancement and cognitive-behavioral therapies and comprises 7 modules organized around 4 goals: (i) Enhance awareness of drinking patterns (assessment and personalized feedback), (ii) Establish and monitor progress towards drinking goal - i.e., moderation or abstinence, (iii) Manage cravings and other problems using in-the-moment tools, and (iv) Connect users with other types of support.
Standard CareOther
Participants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Participants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation. Receives: Other: Standard Care |
| Combined MAUD+SD-App | Experimental | In addition to standard MAUD care, participants assigned to the MAUD+SD-App condition will receive access to the Stand Down app at randomization. Receives: Other: Stand Down mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Heavy Drinking Days (HDD)
Change from baseline to 6-month follow-up in percent heavy drinking days (HDD), defined as >4 drinks per day for women and >5 drinks per day for men, was selected as the primary outcome as it combines both frequency and intensity of drinking and is a clinically meaningful measure of change. HDD will be generated from the Timeline Follow Back (TLFB), a retrospective, calendar-based measure that provides information on quantity/frequency of alcohol use in the past 30 days. Percent HDD will be calculated by dividing the number of HDD during a one-month period by 30 days.
Measured: 6 months post-baseline
Semi-structured qualitative interview data from patients, providers, clinical leaders
[Qualitative] Patient, provider, and clinical leader perspectives regarding barriers and facilitators to adoption, implementation, and sustainability of the Stand Down mobile application in combination with medications for AUD in primary care.
Measured: 3 months post-baseline
Secondary outcomes (14)
Change in Short Inventory of Problems - Revised version (SIP-R)
Change from baseline to 6-month follow-up in the Short Inventory of Problems - Revised version (SIP-R), a 17-item questionnaire used to assess negative consequences from drinking. Items are rated on a 4-pt scale (0=Never, 1= Once or a Few Times, 2 = Once or Twice a Week, 3 = Daily or Almost Daily), which yields a total score. Higher scores reflect greater severity of alcohol-related problems.
Measured: 6 months post-baseline
Change in World Health Organization (WHO) Risk Levels
Change from baseline to 6-month follow-up in WHO risk levels, which are defined by average grams of alcohol consumed per day as calculated for each participant from the Timeline Follow Back (TLFB), a retrospective, calendar-based measure that provides information on quantity/frequency of alcohol use in the past 30 days. Participants are categorized into five levels: abstinent (0 g of alcohol/day), low risk (1-40 g/1-20 g of alcohol/day), medium risk (41-60 g/21-40 g of alcohol/day), high risk (61-100 g/41-60 g of alcohol/day), and very high risk (>101 g/>61 g of alcohol/day), with 14g of alcohol being equivalent to 1 standard drink. Reductions in WHO risk levels have been associated with significant improvements in liver function, AUD severity, and functioning among persons with AUD. WHO risk levels are reported as the percentage of participants in each study group representing each risk level.
Measured: 6 months post-baseline
Change in Client Satisfaction Questionnaire (CSQ) Scores
Change from baseline to 6-month follow-up in the Client Satisfaction Questionnaire (CSQ), an 8-item questionnaire used to assess patient satisfaction with substance use treatment. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Measured: 6 months post-baseline
Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores
Change from baseline to 6-month follow-up in the PHQ-9, a 9-item instrument used to screen, diagnose, and monitor the severity of depression. Each item is rated on a 4-point scale (0=Not at all; 1=Several days; 2=More than half the days; and 3=Nearly every day). The total score can range from 0 to 27, with higher scores indicating greater severity of depression.
Measured: 6 months post-baseline
Change in PTSD Checklist for DSM-5 (PCL-5) Scores
Change from baseline to 6-month follow-up in the PTSD Checklist for DSM-5 (PCL-5), a 20-item instrument used to measure presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Each item is rated on a 5-point scale (0= Not at all; 1= A little bit; 2= Moderately; 3= Quite a bit; and 4= Extremely). The total score can range from 0 to 80, with higher scores indicating greater severity of PTSD.
Measured: 6 months post-baseline
Change in Veterans RAND 12 Item Health Survey Scores
Change from baseline to 6-month follow-up in the Veterans RAND 12 Item Health Survey, a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: 6 months post-baseline
Change in Percent Heavy Drinking Days (HDD)
Change from baseline to 12-month follow-up in in percent HDD, defined as >4 drinks per day for women and >5 drinks per day for men, was selected as the primary outcome as it combines both frequency and intensity of drinking and is a clinically meaningful measure of change. HDD will be generated from the Timeline Follow Back (TLFB), a retrospective, calendar-based measure that provides information on quantity/frequency of alcohol use in the past 30 days. Percent HDD will be calculated by dividing the number of HDD during a one-month period by 30 days.
Measured: 12-months post-baseline
Change in Short Inventory of Problems - Revised version (SIP-R)
Change from baseline to 12-month follow-up in the Short Inventory of Problems - Revised version (SIP-R), a 17-item questionnaire used to assess negative consequences from drinking. Items are rated on a 4-pt scale (0=Never, 1= Once or a Few Times, 2 = Once or Twice a Week, 3 = Daily or Almost Daily), which yields a total score. Higher scores reflect greater severity of alcohol-related problems.
Measured: 12-months post-baseline
Change in World Health Organization (WHO) Risk Levels
Change from baseline to 12-month follow-up in WHO risk levels, which are defined by average grams of alcohol consumed per day as calculated for each participant from the Timeline Follow Back (TLFB), a retrospective, calendar-based measure that provides information on quantity/frequency of alcohol use in the past 30 days. Participants are categorized into five levels: abstinent (0 g of alcohol/day), low risk (1-40 g/1-20 g of alcohol/day), medium risk (41-60 g/21-40 g of alcohol/day), high risk (61-100 g/41-60 g of alcohol/day), and very high risk (>101 g/>61 g of alcohol/day), with 14g of alcohol being equivalent to 1 standard drink. Reductions in WHO risk levels have been associated with significant improvements in liver function, AUD severity, and functioning among persons with AUD. WHO risk levels are reported as the percentage of participants in each study group representing each risk level.
Measured: 12-months post-baseline
Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores
Change from baseline to 12-month follow-up in the PHQ-9, a 9-item instrument used to screen, diagnose, and monitor the severity of depression. Each item is rated on a 4-point scale (0=Not at all; 1=Several days; 2=More than half the days; and 3=Nearly every day). The total score can range from 0 to 27, with higher scores indicating greater severity of depression.
Measured: 12-months post-baseline
Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment
The total number of participants who received VA outpatient substance use disorder treatment as assessed from visits documented in the VA electronic health record data.
Measured: 12-months post-baseline
Number of Participants Receiving VA Emergency Department Services
The total number of participants who received VA emergency department services as assessed from visits documented in the VA electronic health record data.
Measured: 12-months post-baseline
Change in PTSD Checklist for DSM-5 (PCL-5) Scores
Change from baseline to 12-month follow-up in the PTSD Checklist for DSM-5 (PCL-5), a 20-item instrument used to measure presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Each item is rated on a 5-point scale (0= Not at all; 1= A little bit; 2= Moderately; 3= Quite a bit; and 4= Extremely). The total score can range from 0 to 80, with higher scores indicating greater severity of PTSD.
Measured: 12-months post-baseline
Change in Veterans RAND 12 Item Health Survey Scores
Change from baseline to 12-month follow-up in the Veterans RAND 12 Item Health Survey, a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: 12-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following completion of informed consent and baseline assessments, participants will be randomized in a 1:1 ratio to MAUD+SD-App or MAUD only conditions.
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eric J. Hawkins, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303778
- Sponsor's protocol ID
- IIR 22-141
- Other IDs
- 1I01HX003742-01A1, HX003742-01A1
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining a Smartphone App With Medications to Manage Heavy Drinking
- ClinicalTrials.gov ID
- NCT06303778
- Acronym / sponsor ID
- IIR 22-141
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- alcohol use disorder, substance use disorder, medications for AUD, smartphone app, primary care, mobile health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally.
Detailed description
Background: Alcohol use disorder (AUD) affects 1 in 10 Veterans and is associated with significant morbidity and mortality. However, few individuals receive evidenced-based psychosocial interventions or medications for AUD (MAUD). Common barriers to treatment include long wait times, stigma, and distance from treatment facilities. Despite clinical guidelines and evidence indicating superior outcomes, even fewer individuals receive MAUD and psychosocial interventions conjointly. The VA prioritizes expanding access to AUD interventions in primary care, but it is difficult to deliver psychosocial interventions in primary care, and care often includes MAUD only. Smartphone mobile applications (apps) that deliver psychosocial interventions concurrent with MAUD may address the gap between recommended and current practices for AUD and appeal to Veterans who prefer to receive their AUD care in primary care. Alcohol intervention apps have been associated with improved drinking-related and mental health outcomes. Self-monitoring of alcohol use, a common feature in apps, may also increase MAUD adherence. Step Away, an app for self-management of alcohol use problems, is designed to guide development and use of personalized strategies to moderate or abstain from drinking. In single-arm cohort studies, the investigators assessed the acceptability and usability of Step Away and Stand Down (SD-App), the Veteran version of the app and focus of this proposal, among Veterans with alcohol use problems. The apps received favorable ratings regarding perceived effectiveness, efficiency, and overall satisfaction, and were associated with reductions in heavy drinking days and drinking-related consequences.
Significance: This study has the potential to substantially improve Veterans' receipt of guideline-concordant AUD care and support national VA initiatives to increase access to AUD care in general healthcare clinics.
Innovation \& Impact: To the investigators' knowledge, no prior study has evaluated the effectiveness of an alcohol-related intervention, delivered by smartphone, with MAUD in primary care. Smartphone apps can be scaled up at relatively low cost, potentially saving lives and improving the quality of care of tens of thousands of Veterans.
Specific Aims: The two aims are to: 1) determine whether MAUD plus SD-App offered to primary care patients diagnosed with AUD, compared to MAUD only, results in (a) greater reductions in heavy drinking days, from baseline to 6-months (primary), (b) greater improvements in alcohol consequences, alcohol use risk levels, and mental health outcomes, from baseline to 6-months (secondary), 2) conduct a process evaluation to identify factors that influence the adoption, implementation, and sustainability of SD-App in combination with MAUD in VA primary care from Veterans', clinical pharmacist specialists' and clinical leaders' perspectives. The investigators will also explore whether MAUD plus SD-App increases MAUD 6-month adherence relative to SD-App alone.
Methodology: Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, this Hybrid 1 effectiveness-implementation trial will enroll 330 Veterans across 15 VA sites. Veterans between ages 18-80, meeting AUD criteria, and planning to initiate MAUD will be randomized to MAUD+SD-App or MAUD only. Participants randomized to MAUD+SD-App will receive access to SD-App. MAUD will be prescribed by VA clinical prescribers per standard care. The primary and secondary outcomes will be assessed at baseline, 3-, 6- and 12-months using participant self-report and electronic medical record data. The investigators will complete qualitative interviews to assess Veterans', clinical pharmacists', and clinical leaders' perspectives on barriers and facilitators to adoption, implementation, and sustainability of SD-App in combination with MAUD in primary care.
Next Steps/Implementation: If MAUD+SD-App improves drinking outcomes, the investigators will work closely with the operations partners to review study findings and to develop a tailored implementation strategy to support widespread implementation across VA primary care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following completion of informed consent and baseline assessments, participants will be randomized in a 1:1 ratio to MAUD+SD-App or MAUD only conditions.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Standard CareParticipants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation. |
| Combined MAUD+SD-App | Experimental | Other: Stand Down mobile appIn addition to standard MAUD care, participants assigned to the MAUD+SD-App condition will receive access to the Stand Down app at randomization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1) diagnosed with an alcohol use disorder (AUD) and report 4 heavy drinking days (HDD)
- 2) enrolled in VA primary care
- 3) planning to initiate medications for alcohol use disorder (MAUD), as determined by a medication order
- 4) willing to be randomized
- 5) Android or iPhone smartphone owners
Key exclusion criteria (4 listed)
- 1) past 30-day participation in VA or non-VA substance use disorder (SUD) treatment
- 2) prior episode of medications for alcohol use disorder receipt in the last 30 days (initiation of a new episode of MAUD in the 7 days prior to screening allowed)
- 3) plans to be or are pregnant
- 4) severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol, as determined by the referring provider. Veterans aged >80 were excluded because ownership and use of mHealth apps decreases with advancing age. Participants who enter substance use disorder specialty care following randomization will be allowed to continue in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stand Down mobile appThe Stand Down mobile app is a smartphone-based stand-alone intervention designed to help persons manage drinking and alcohol-related problems on their own. The app is based on principles of motivational enhancement and cognitive-behavioral therapies and comprises 7 modules organized around 4 goals: (i) Enhance awareness of drinking patterns (assessment and personalized feedback), (ii) Establish and monitor progress towards drinking goal - i.e., moderation or abstinence, (iii) Manage cravings and other problems using in-the-moment tools, and (iv) Connect users with other types of support. | Other | Combined MAUD+SD-App |
| Standard CareParticipants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation. | Other | Standard Care |
Primary outcome
Change in Percent Heavy Drinking Days (HDD)
Time frame: 6 months post-baseline
Change from baseline to 6-month follow-up in percent heavy drinking days (HDD), defined as >4 drinks per day for women and >5 drinks per day for men, was selected as the primary outcome as it combines both frequency and intensity of drinking and is a clinically meaningful measure of change. HDD will be generated from the Timeline Follow Back (TLFB), a retrospective, calendar-based measure that provides information on quantity/frequency of alcohol use in the past 30 days. Percent HDD will be calculated by dividing the number of HDD during a one-month period by 30 days.
Semi-structured qualitative interview data from patients, providers, clinical leaders
Time frame: 3 months post-baseline
[Qualitative] Patient, provider, and clinical leader perspectives regarding barriers and facilitators to adoption, implementation, and sustainability of the Stand Down mobile application in combination with medications for AUD in primary care.
14 secondary outcomes
Change in Short Inventory of Problems - Revised version (SIP-R)
Time frame: 6 months post-baseline
Change in World Health Organization (WHO) Risk Levels
Time frame: 6 months post-baseline
Change in Client Satisfaction Questionnaire (CSQ) Scores
Time frame: 6 months post-baseline
Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores
Time frame: 6 months post-baseline
Change in PTSD Checklist for DSM-5 (PCL-5) Scores
Time frame: 6 months post-baseline
Change in Veterans RAND 12 Item Health Survey Scores
Time frame: 6 months post-baseline
Change in Percent Heavy Drinking Days (HDD)
Time frame: 12-months post-baseline
Change in Short Inventory of Problems - Revised version (SIP-R)
Time frame: 12-months post-baseline
Change in World Health Organization (WHO) Risk Levels
Time frame: 12-months post-baseline
Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores
Time frame: 12-months post-baseline
Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment
Time frame: 12-months post-baseline
Number of Participants Receiving VA Emergency Department Services
Time frame: 12-months post-baseline
Change in PTSD Checklist for DSM-5 (PCL-5) Scores
Time frame: 12-months post-baseline
Change in Veterans RAND 12 Item Health Survey Scores
Time frame: 12-months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric J. Hawkins, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stand Down mobile app in people with Alcohol Use Disorder (AUD), run by VA Office of Research and Development at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric J Hawkins, PhD ((206) 764-2743, eric.hawkins@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent Heavy Drinking Days (HDD) (time frame: 6 months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.